Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear

NCT05789810 | Completed DMC

• 1 other identifier: Çankırı Karatekin Üniversitesi
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental, prospective, and randomized controlled study was designed to determine and compare the effects of applying manual pressure and ShotBlocker methods in reducing pain and fear during the subcutaneous insulin injection for children with Type 1 diabetes mellitus. A parallel trial design was used describing two intervention (manual pressure and ShotBlocker) and a control group (no intervention used) as the third arm. The study population consisted of children aged 6-12 years, diagnosed with Type 1 diabetes mellitus, administered insulin injections, able to cognitively score their pain and fear levels, who wanted to participate in the study, and gave verbal and written consent to participate in the study.The study sample composed of 90 children based on confidence interval of 95% and statistical power of 80%. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.

Conditions

Pain; Fear

Outcome Measures

Primary Outcomes (2)

• Pain Severity

  Wong-Baker FACES Pain Rating Scale was used to assess the pain levels of children before and after the insulin administration. This scale was administered to the children, their parents, and a researcher (the first author) within 5 minutes before and immediately after the insulin administration. The scale was scored blindly before and after the insulin administration so that they were not affected by each other.

  5 Months

• Fear Severity

  Child Fear Scale was used to assess pain-related fear levels of children before and after the insulin administration. This scale was administered to the children, their parents, and a researcher (the first author) within 5 minutes before and immediately after the insulin administration. The scale was scored blindly before and after the insulin administration so that they were not affected by each other.

  5 Months

Study Arms (3)

Manuel pressure group

EXPERIMENTAL

10-second manual pressure was applied on the insulin injection area. The injection point was pressed by the diabetes nurse's right thumb over the site until resistance was felt and the pressure was then maintained for 10 seconds before the insulin injection. Then insulin injection was administered.

Other: Manuel pressure

ShotBlocker group

EXPERIMENTAL

ShotBlocker device was placed in the insulin injection site by contacting the protruding surface with the skin and was kept throughout the injection. The injection was applied through the opening at the middle of the tool.

Other: ShotBlocker

Control group:

EXPERIMENTAL

No intervention was performed to reduce pain and fear.

Other: Control

Interventions

Manuel pressure OTHER

10-second manual pressure was applied on the insulin injection area.

Manuel pressure group

ShotBlocker OTHER

ShotBlocker device was placed in the insulin injection site by contacting the protruding surface with the skin and was kept throughout the injection. The injection was applied through the opening at the middle of the tool.

ShotBlocker group

Control OTHER

No intervention was performed to reduce pain and fear.

Control group:

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• administered insulin injection, able to score cognitively pain and fear levels, who want to participate in research children who gave verbal and written consent to participate in the study

Sponsors & Collaborators

• Çankırı Karatekin University: lead
• Istanbul Saglik Bilimleri University: collaborator

Study Sites (1)

Çankırı Karatekin Univesity

Çankiri, 18200, Turkey (Türkiye)

Location

Related Publications (1)

• Girgin BA, Gol I, Gozen D, Carikci F, Kirmizibekmez H. Effects of applications manual pressure and shotblocker to reduce needle-related pain and fear in children with type 1 diabetes mellitus. J Pediatr Nurs. 2023 Nov-Dec;73:84-90. doi: 10.1016/j.pedn.2023.08.024. Epub 2023 Aug 30.

  PMID: 37651942 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: Interventional

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: September 10, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)